Garnier Ombrelle Ultra Light Advanced Broad Spectrum SPF 50 Plus Sunscreen Water Resistant 80 Minutes Weightless Body by L'OREAL USA PRODUCTS INC / Dimensional Merchandising Inc. Drug Facts

Garnier Ombrelle Ultra Light Advanced Broad Spectrum SPF 50 Plus Sunscreen Water Resistant 80 Minutes Weightless Body by

Drug Labeling and Warnings

Garnier Ombrelle Ultra Light Advanced Broad Spectrum SPF 50 Plus Sunscreen Water Resistant 80 Minutes Weightless Body by is a Otc medication manufactured, distributed, or labeled by L'OREAL USA PRODUCTS INC, Dimensional Merchandising Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

GARNIER OMBRELLE ULTRA LIGHT ADVANCED BROAD SPECTRUM SPF 50 PLUS SUNSCREEN WATER RESISTANT 80 MINUTES WEIGHTLESS BODY- avobenzone, ecamsule, homosalate, octisalate, octocrylene and oxybenzone lotion 
L'OREAL USA PRODUCTS INC

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Drug Facts

Active ingredients

Avobenzone 3%
Ecamsule 2%
Homosalate 10%
Octisalate 5%
Octocrylene 5%,
Oxybenzone 6%

Warnings

For external use only. Do not use on broken skin. When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If swallowed, get medical help or
contact a poison control centre right away.

Directions 

Adults and children 6 months and up. Apply generously and evenly 15 minutes before sun exposure. Reapply at least every 2 hours, after 80 minutes of swimming or sweating and immediately after towel drying.

Inactive ingredients

aqua, cyclopentasiloxane, alcohol denat., cyclohexasiloxane, styrene/acrylatescopolymer, silica, dicaprylyl ether, PEG-30 dipolyhydroxystearate, dimethicone, triethanolamine, glycerin, nylon-12 polymet h y l s i lsesquioxane, dicaprylyl carbonate, tocopherol, dodecene, phenoxyethanol, PEG-8 laurate, poly C10-30 alkyl acrylate, poloxamer 407, caprylyl glycol, disteardimonium hectorite, disodium EDTA, lauryl PEG/PPG-18/18 methicone

image of a carton

GARNIER OMBRELLE ULTRA LIGHT ADVANCED BROAD SPECTRUM SPF 50 PLUS SUNSCREEN WATER RESISTANT 80 MINUTES WEIGHTLESS BODY 
avobenzone, ecamsule, homosalate, octisalate, octocrylene and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 49967-833
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
ECAMSULE (UNII: M94R1PM439) (ECAMSULE - UNII:M94R1PM439) ECAMSULE20 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE50 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE60 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
ALCOHOL (UNII: 3K9958V90M)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
DICAPRYLYL ETHER (UNII: 77JZM5516Z)  
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERIN (UNII: PDC6A3C0OX)  
NYLON-12 (UNII: 446U8J075B)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
TOCOPHEROL (UNII: R0ZB2556P8)  
DODECENE (UNII: WYE669F3GR)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PEG-8 LAURATE (UNII: 762O8IWA10)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 49967-833-011 in 1 CARTON03/22/201708/30/2022
1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
export only03/22/201708/30/2022
Labeler - L'OREAL USA PRODUCTS INC (002136794)
Establishment
NameAddressID/FEIBusiness Operations
Dimensional Merchandising Inc.076693183manufacture(49967-833) , pack(49967-833)

Revised: 1/2023